Guilin Zizhu Latex Co., Ltd – FDA Warning Letter, Mar 7, 2015

On March 2-7, 2015, an FDA inspection of Guilin Zizhu Latex Co., Ltd. in China, a manufacturer of natural rubber latex condoms, revealed significant violations of the Quality System (QS) regulation (21 CFR Part 820), rendering their devices adulterated under the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Failure to validate processes (21 CFR 820.75(a)):** Specifically, validation was not performed for active condom production and performance qualification for various processes and equipment. The firm's response was inadequate, lacking retrospective review for other processes and previously manufactured condoms. 2. **Failure to ensure suitability of inspection, measuring, and test equipment (21 CFR 820.72(a)):** The firm failed to validate automatic condom testing equipment. The response was inadequate as it did not confirm the equipment's capability for valid results. 3. **Failure to validate computer software (21 CFR 820.70(i)):** Software for condom production machines was not validated. The firm's response was inadequate, lacking retrospective review for other software and previously manufactured condoms. 4. **Failure to prevent contamination (21 CFR 820.70(e)):** A floor mop sponge was used to remove cleaning solution from condom molds without proper evaluation of its effects on product quality. This was